The present invention relates generally to the delivery of a beneficial agent to a patient. More specifically, the present invention relates to a device for reconstituting a beneficial agent to be delivered to a patient.
Many drugs are stored in a powdered state, to increase their shelf life for example. In order for powdered drugs to be given intravenously to a patient, the drugs must first be placed in liquid form. To this end, these drugs are mixed or reconstituted with a diluent before being delivered intravenously to a patient. The diluents may be, for example, a dextrose solution, a saline solution, or even water. Typically these drugs are stored in powdered form in glass vials or ampules.
Other drugs, although in a liquid state, must still be diluted before administration to a patient. For example, some chemotherapy drugs are stored in glass vials or ampules, in a liquid state, but must be diluted prior to use. As used herein, reconstitution means to place the powdered drug in a liquid state, as well as, includes the dilution of a liquid drug.
Typically, the powdered drug and diluent are packaged separately. Drugs may be packaged separate from the diluent for various reasons. One of the principal reasons is that many drugs do not retain their chemical and physical stability when mixed with a diluent and thus cannot be stored for any substantial period of time. Furthermore, many companies that make the drug do not make the diluent, and vice versa.
It is necessary for the doctor, pharmacist, nurse, or other medical personnel to mix the drug with diluent prior to use. The reconstitution of the drug presents a number of problems. The reconstitution procedure is time consuming and requires aseptic technique. Furthermore, the proper drug and diluent must be utilized or the product must be disposed of.
The reconstitution procedure should be performed under sterile conditions. In some procedures for reconstituting, maintaining sterile conditions is difficult. Moreover, some drugs, such as chemotherapy drugs, are toxic and exposure to the operator during the reconstitution procedure can be dangerous.
One way of reconstituting a powdered drug is to inject the liquid diluent directly into the drug vial. This can be performed by use of a combination syringe and syringe needle having diluent therein. In this regard, drug vials typically include a pierceable rubber stopper. The rubber stopper of the drug vial is pierced by the needle, and liquid in the syringe is then injected into the vial. The vial is shaken to mix the powdered drug with the liquid. After the liquid and drug are mixed, the resultant liquid is then withdrawn back into the syringe. The syringe is then withdrawn and the drug can then be injected into the patient.
Another method of drug administration is to inject the reconstituted drug, contained in the syringe, into a parenteral solution container. Examples of such containers include the Minibag (TM) flexible parenteral solution container or VIAFLEX (R) flexible parenteral solution container sold by Baxter Healthcare Corporation of Deerfield, Ill. These parenteral solution containers may already have therein dextrose or saline solutions. The drug is injected into the container, mixed with the solution in the parenteral solution container and delivered through an intravenous solution administration set to a vein access site of the patient.
Another method for reconstituting a powdered drug utilizes a reconstitution device sold by Travenol Laboratories, product code No. 2B8064. That device includes a double pointed needle and guide tubes mounted around both ends of the needle. This reconstitution device is utilized to place the drug vial in flow communication with a flexible-walled parenteral solution container. Once the connection is made, liquid in the solution container may be forced into the drug vial by squeezing the solution container. The vial is then shaken. The liquid in the vial is withdrawn by squeezing air from the solution container into the vial. When compression of the flexible walled solution container is stopped, the pressurized air in the vial acts as a pump to force the liquid in the vial back into the solution container.
An improvement to this product is the subject of U.S. Pat. No. 4,607,671 to Aalto et al., assigned to the assignee of the present invention. The device of that invention includes a series of bumps on the inside of a sheath to grip a drug vial. These bumps hinder the inadvertent disconnection of the device and the vial.
U.S. Pat. No. 4,759,756 discloses a reconstitution device wherein, in an embodiment, the reconstitution device includes an improved vial adaptor and bag adaptor that permit the permanent coupling of a vial and liquid container. The bag adaptor can be rotatable relative to the vial adaptor to operate the valve including a stem channel and a base post on the vial adaptor, a base segment channel and a cut out portion of a rim on the bag adaptor and a sealing segment disposed between the vial and the bag adaptor.
Another form of reconstitution device is seen in U.S. Pat. No. 3,976,073 to Quick et al., assigned to the assignee of the present invention. Yet another type of reconstitution device is disclosed in U.S. Pat. No. 4,328,802 to Curley et al., entitled "Wet-Dry Syringe Package" which includes a vial adaptor having inwardly directed retaining projections to firmly grip the retaining cap lip of a drug vial to secure the vial to the vial adaptor. The package disclosed by Curley et al. is directed to reconstituting a drug by use of a syringe.
Other methods for reconstituting a drug are shown, for example, in U.S. Pat. Nos. 4,410,321 to Pearson et al., entitled "Close Drug Delivery System"; 4,411,662 and 4,432,755 to Pearson, both entitled "Sterile Coupling"; and 4,458,733 to Lyons entitled "Mixing Apparatus", all assigned to the assignee of the present invention.
Other related patents include U.S. Pat. No. 3,872,867 to Kilinger entitled "Wet-Dry Additive Assembly"; U.S. Pat. No. 3,841,329 to Kilinger entitled "Compact Syringe"; U.S. Pat. No. 3,826,261 to Kilinger entitled "Vial and Syringe Assembly"; U.S. Pat. No. 3,826,260 to Kilinger entitled "Vial and Syringe Combination"; U.S. Pat. No. 3,378,369 to Kilinger entitled "Apparatus for Transferring Liquid Between a Container and a Flexible Bag"; and German specification DE OS 36 27 231.
In reconstituting a drug, contained in a drug vial, with a diluent, without the use of an intermediary syringe, several problems exist. In some cases, the drug must be packaged separate from the diluent because certain drug's efficacy, in the presence of moisture is short, sometimes as short as 24 hours. Accordingly, once the drug is reconstituted, it must be used in a relatively short time period. Added to this is the fact that drug prescriptions are often changed and therefore, if the drug is reconstituted by the pharmacists, the prescription may change prior to use of the drug. Due to the short efficacy of some drugs, this can result in the drug having to be disposed of.
Because many drugs are very expensive, it would be highly desirable to provide a reconstitution device that would prevent dilution or reconstitution of erroneously selected drugs or diluent; once the drugs are reconstituted or diluted, they must be used.
Further, it can be appreciated that it is highly desirable to provide a device that prevents contamination of the drug in the vial and the puncturing members that puncture the parenteral bag and vial. Also, the connection between the vial and the parenteral bag must be effectively sealed to prevent leakage of the connecting device.